Upon intravenous administration of SPY AGENTTMGREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

Upon interstitial administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Device Description

The 780 nm L11 LED Light Source with AIM is part of the 780 nm Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The 780 nm L11 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.

AI/ML Overview

The provided text describes a 510(k) submission for the "780 nm L11 LED Light Source with AIM" device and mentions that the device passed several performance bench tests. However, it explicitly states:

"NOTE: The 780 nm L11 LED Light Source does not require clinical studies to support the determination of substantial equivalence."

This means that while the device underwent technical and performance testing, there wasn't a clinical study to prove the device meets clinical acceptance criteria. Therefore, most of the requested information regarding clinical acceptance criteria, sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical performance is not available in the provided text.

Here's a breakdown of what can be extracted based on the input:

1. A table of acceptance criteria and the reported device performance

The provided document lists performance tests and indicates a "PASS" for each, suggesting these tests represent the acceptance criteria for those specific aspects. Clinical acceptance criteria are not mentioned as clinical studies were not required.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Software	Conformance to IEC 62304:2015	PASS
Performance - Bench - Laser Power Output	Implied specification adhered to	PASS
Spatial Uniformity	Implied specification adhered to	PASS
Minimum Detectable Fluorescence	Implied specification adhered to	PASS
Fluorescence Detection Depth	Implied specification adhered to	PASS
Clinically Meaningful Limits of Detection	Implied specification adhered to	PASS
Signal to noise	Implied specification adhered to	PASS
Dynamic Range	Implied specification adhered to	PASS
Localization	Implied specification adhered to	PASS

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no clinical test set was used for a study proving clinical acceptance criteria. The performance tests were bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test set was used requiring expert ground truth for clinical acceptance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document explicitly states that clinical studies were not required. The device is a light source, not an AI-assisted diagnostic tool for "human readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to an algorithm's performance. The "780 nm L11 LED Light Source with AIM" is a medical device providing illumination and imaging, not a standalone AI algorithm. While it has an "AIM" (Advanced Imaging Modality) system, the document focuses on the light source itself and its functionality for fluorescence and transillumination, not an independent algorithm for diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical study requiring a ground truth for diagnostic or clinical performance was conducted. The "PASS" for the bench tests indicates adherence to engineering or performance specifications.

8. The sample size for the training set

Not applicable, as no clinical training set was used for an AI algorithm.

9. How the ground truth for the training set was established

Not applicable, as no clinical training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Stryker Michelle Hughes Senior Staff Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138

June 29, 2022

Re: K221611

Trade/Device Name: 780 nm L11 LED Light Source with AIM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN Dated: June 1, 2022 Received: June 3, 2022

Dear Michelle Hughes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Neil R. P. Ogden, MS Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221611

Device Name 780 nm L11 LED Light Source with AIM

Indications for Use (Describe)

780 nm L11 LED Light Source with AIM and SafeLight Cable:

The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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stryker

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92.

510(k) Number : K221611

Submitter:

Applicant:	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person:	Michelle HughesSenior Staff Regulatory Affairs SpecialistEmail: michelle.hughes@stryker.comPhone: (408) 754-2473
Date Prepared:	June 28, 2022

Subject Device:

Name of Device:	780 nm L11 LED Light Source with AIM
Common orUsual Name	Light Source, Illuminator
ClassificationName:	Confocal Optical Imaging1 (21 C.F.R. §876.1500)Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020)Light Source, Fiberoptic, Routine3 (21 C.F.R. §876.4020)Endoscope, Neurological4 (21 C.F.R. §882.1480)
Regulatory Class:	II
Product Code:	OWN1FSC2FCW3GWG4
510(k) ReviewPanel:	General & Plastic Surgery1Gastroenterology/ Urology2,3Neurology4

IWhen used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging

2When used to transilluminate the ureter during open or laparoscopic surgical procedures

3When used to provide standard endoscopic visible light to support real-time endoscopic visible imaging.

4When used to provide standard endoscopic visible light and near-infrared imaging during minimally invasive cranial neurosurgery and endonasal skull base surgery.

Predicate Device(s):

780 nm L11 LED Light Source with AIM (primary predicate)	K214046
VS3 Iridium System (reference device)	K210265

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Device Description:

Indications for Use:

Upon intravenous administration of SPY AGENT™GREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

Upon interstitial administration of SPY AGENT GREEN, the 780 mm L11 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system. including lymphatic vessels and lymph nodes.

The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

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stryker

Comparison of Technological Characteristics with the Predicate Device:

Item	Subject DevicePredicate Devices
	780 nm L11 LED Light Sourcewith AIM	780 nm L11 LED LightSource with AIM(primary predicate)	VS3 Iridium System(reference device)
Manufacturer	Stryker	Same as subject device.	Visionsense Ltd.(Medtronic)
SubmissionReference	Current submission	K214046	K210265
Intended Use	Endoscopic white light and near-infrared illumination andimaging during endoscopicprocedures.	Same as subject device	Same as subject device
Indications forUse	NOTE 1	NOTE 2	NOTE 3
Imaging Modes	White lightNear-infrared fluorescenceNear-infrared transillumination	Same as subject device.	White lightNear-infrared fluorescence
Imaging Agents	SPY AGENT™ GREEN(indocyanine green for injection,USP)pafolacianine	SPY AGENT™ GREEN(indocyanine green forinjection, USP)	Indocyanine Greenpafolacianine
Principles ofOperation	Via an optical light guide,endoscope and coupler, light isprojected from a light source andeither reflected or absorbed andfluoresced onto one or morecomplementary metal oxidesemiconductor image sensorswhich acquire a continuousstream of image data. The imagedata is processed to provide avideo stream that is then sent toa display for viewing.	Same as subject device.	Same as subject device.
SystemComponents	Light Source (subject of thissubmission)SafeLight CableCamera SystemLaparoscopesIRIS Ureteral KitNOTE: This represents thecomponents of the AIM System.	Same as subject device.	Xenon Light SourceLaser Light SourceLight CableCamera SystemLaparoscope
Safety Standards	IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60601-1-6IEC 60825-1	Same as subject device.	Same as subject device.
Laser SafetyClassification	Class 1M	Same as subject device.	Class 3R
Light Source/Laser	RGB LEDs/Infrared Laser	Same as subject device.	Xenon Bulb/Infrared Laser
Maximum output	1300-1700 mW	Same as subject device.	500 mW
Item	Subject Device	Predicate Devices
	780 nm L11 LED Light Sourcewith AIM	780 nm L11 LED LightSource with AIM(primary predicate)	VS3 Iridium System(reference device)
ExcitationWavelength(s)	Near-infrared fluorescence: 780 nmNear-infrared transillumination:830 nm	Same as subject device.	Near-infrared fluorescence:785 nm
SystemDetectionBandwidth	IR Spectrum: 795 nm-900 nm	Same as subject device.	IR Spectrum: 800 nm-850 nm
System Angle ofview	0° and 30°	Same as subject device.	Same as subject device.
System Field ofview	70° - 80°	Same as subject device	70° - 95°

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NOTE 1: Upon intravenous administration of SPY AGENTM GREEN (indocyanine green for injection, USP), the 780 mm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for bilization. Additionally, the 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstital administration of SPY AGENT GREEN, the 780 mm L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymph nodes. Upon administration and use of patolacianne consistent with its approved label, the 780 nm L11 LED Light Source and SafeLight™ Cable is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The 700 nm L 1 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparossopic surgical procedures.

NOTE 2: Upon intravenous administration of SPY AGENTM GREEN (indocyanine green for injection, USP), the 780 mm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for bilization. Additionally, the 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstital administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymph nodes. The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

NOTE 3: Upon intravenous administration and use of an ICG consistent with its approved labeling, the Iridium Module of the VS3-IR System is used to perform intraoperative fluorescence angiography. Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-IR System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.Upon administration and use of pafolacianine consistent with its approved labeling, the VS3-IR 785 mm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

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Image /page/8/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and black. The letters are closely spaced together, and the overall appearance is modern and clean. The word is likely a logo or brand name.

Performance Data:

Test	Method	Result
Software	In accordance with IEC 62304:2015	PASS
Performance -Bench	Laser Power Output	PASS
	Spatial Uniformity	PASS
	Minimum Detectable Fluorescence	PASS
	Fluorescence Detection Depth	PASS
	Clinically Meaningful Limits of Detection	PASS
	Signal to noise	PASS
	Dynamic Range	PASS
	Localization	PASS

NOTE: The 780 nm L11 LED Light Source with AlM is not patient contacting; therefore, biocompatibility testing was not required to support the determination of substantial equivalence.

NOTE: The 780 nm L11 LED Light Source does not require clinical studies to support the determination of substantial equivalence.

Conclusions:

The 780 nm L11 LED Light Source with AIM is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. In summary, the 780 nm L11 LED Light Source with AIM is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate devices.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.